Wei Ping Low
Summary
Experienced analytical professional with a passion for public health and a track record of success in the food safety and pharmaceuticals quality control. Extensive technical expertise on analytical tests and advanced instrumentation. Highly knowledgeable on method lifecycle management (development, qualification, validation), quality system standards in testing laboratories (ISO/IEC 17025) and cGMP in the pharmaceutical industry. Possesses great communication and project management skills to collaborate effectively with cross-functional teams to achieve project deliverables.
Overview
11
11
years of professional experience
Work History
Senior QC Specialist
GSK Biologicals
03.2023 - Current
- Completed method validation activities for new product introduction to achieve milestone for product release
- Demonstrated accountability for timely release of QC results for downstream forward processing
- Led troubleshooting efforts for atypical analytical testing and equipment issues to minimize testing downtime
Senior Expert
Tessa Therapeutics - QC ASAT
08.2022 - 02.2023
- Developed method comparability protocol to support method bridging studies with external clinical laboratory for pivotal trials
- Contributed as task force member to revamp and improve work flow for critical materials management
- Participated and contributed to internal audits and audit readiness activities in preparation of health regulatory audit for GMP certification
Senior Associate
Amgen Singapore Manufacturing - Quality Control (Technical Support)
01.2019 - 08.2022
- Led method qualification, transfer, and validation for New Product Introductions (NPIs) as subject matter expert for chromatographic (HIC, IEX, SEC, HILIC, RP) and general (Polysorbate using SPE and LLE) methods.
- Collaborated with cross-functional teams (Analytical Sciences, Global Method Implementation Team, QC network) and communicated effectively to ensure new methods were introduced for NPIs within project timelines.
- Conducted root cause analysis to identify cause of unexpected or OOS results, and successfully executed equipment qualifications (Raman spectrometer, Waters HPLC/UPLCs) to expand laboratory testing capacity and capability for NPIs.
- Provided training and technical expertise to junior analysts on chromatographic and general testing methods, improving cross-training capability of laboratory and fostering culture of learning.
- Revamped and harmonized training qualifications, allowing for efficient and consistent knowledge transfer to trainees.
Business Quality Executive
Johnson & Johnson Pte Ltd – Business Quality
05.2018 - 12.2018
- Reviewed batch records for inbound and repackaged consumer products in compliance with regulatory and internal Quality System standards.
- Coordinated and collaborated with cross-functional teams to ensure timely launch of new products in local market through effective closure of change control activities.
- Participated in Quality System Management Reviews to demonstrate adequacy of current Quality System standards.
Quality Control Chemist
Pfizer Asia Pacific Pte Ltd – Quality Operations
06.2015 - 05.2018
- Spearheaded a training project as part of laboratory improvement activities, streamlining the training process and improving the testing competency of laboratory analysts.
- Demonstrated sound project management by successfully completing new equipment qualification in compliance with cGMP and 21 CFR Part 11 within tight project deadline.
- Reviewed analytical test results of API to ensure compliance with cGMP and timely release of high-quality API to meet market demand.
- Performed laboratory investigations for out-of-specification test results using good problem-solving and analytical skills to identify root cause and implement effective corrective and preventive actions to minimize recurrence.
Analytical Scientist
Health Sciences Authority – Food Safety Division
08.2012 - 06.2015
- Developed, validated and implemented in-house test methods to expand technical capability in detection of food contaminants using chromatographic and mass spectrometric techniques
- Optimized sample preparation processes which led to improvement in work productivity and process efficiency to achieve 20% reduction in test duration
- Identified and evaluated root cause of non-conformity issue with drastic impact on reliability and quality of analytical results and implemented corrective action to resolve non-compliance
- Participated with laboratory officers in various local/international proficiency testing programs to demonstrate testing competency of laboratory
- Successfully achieved accreditation by SAC-SINGLAS for newly developed analytical methods, demonstrating compliance with requirements of ISO/IEC 17025
Education
Bachelor of Science - Chemistry
National University of Singapore
Singapore05.2012
Skills
- Technical Troubleshooting
- Analytical Equipment (LC, GC, MS, UV)
- Continuous Improvement
- Current Good Manufacturing Practices
- Analytical Methodology Validation
- Laboratory Equipment Qualification
- Systems and Analytical Software (TrackWise, Minitab, Empower)
- Strong Analytical Skills
- Effective Communication
Timeline
Senior QC Specialist
GSK Biologicals
03.2023 - Current
Senior Expert
Tessa Therapeutics - QC ASAT
08.2022 - 02.2023
Senior Associate
Amgen Singapore Manufacturing - Quality Control (Technical Support)
01.2019 - 08.2022
Business Quality Executive
Johnson & Johnson Pte Ltd – Business Quality
05.2018 - 12.2018
Quality Control Chemist
Pfizer Asia Pacific Pte Ltd – Quality Operations
06.2015 - 05.2018
Analytical Scientist
Health Sciences Authority – Food Safety Division
08.2012 - 06.2015
Bachelor of Science - Chemistry
National University of Singapore
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